In the 1970s, the technique of percutaneous transluminal coronary angioplasty (PTCA) was developed for the treatment of atherosclerosis. Atherosclerosis is the build-up of fatty deposits or plaque on the inner walls of a patient's arteries; these lesions decrease the effective size of the artery lumen and limit blood flow through the artery, prospectively causing a myocardial infarction or heart attack if the lesions occur in coronary arteries that supply oxygenated blood to the heart muscles. In the angioplasty procedure, a guide wire is inserted into the femoral artery and is passed through the aorta into the diseased coronary artery. A catheter having a balloon attached to its distal end is advanced along the guide wire to a point where the sclerotic lesions limit blood flow through the coronary artery. The balloon is then inflated, compressing the lesions radially outward against the wall of the artery and substantially increasing the size of its internal lumen, to improve blood circulation through the artery.
Increasingly, stents are being used in place of or in addition to PTCA for treatment of atherosclerosis, with the intent of minimizing the need to repeatedly open an atherosclerotic artery. Although a number of different designs for stents exist in the prior art, all are generally configured as elongate cylindrical structures that are provided in a first state and can assume a second, different state, with the second state having a substantially greater diameter than the first state. A stent is implanted in a patient using an appropriate delivery system for the type of stent being implaced within the patient's arterial system. There are two basic types of stents—those that are expanded radially outward due to the force from an inflated angioplasty type balloon, such as the Palmaz-Schatz stent, the Gianturco-Roubin stent and the Strecker stent, and those that are self expanding, such as the Maass double helix spiral stent, the Nitinol stent (made of nickel titanium memory alloy), the Gianturco stent and the Walistent. Problems with the Maass double helix spiral stent and the Nitinol stent have limited their use.
Stents are sometimes used following a PTCA procedure if the artery is totally occluded or if the lesions have occluded a previously placed surgical graft. Typically, a stent constrained within an introducer sheath is advanced to a site within the patient's artery through a guide catheter. For the balloon expanded type, after the introducer sheath is retracted, a balloon disposed inside the stent is inflated to a pressure ranging from about six to ten atmospheres. The force produced by the inflated balloon expands the stent radially outward beyond its elastic limit, stretching the vessel and compressing the lesion to the inner wall of the vessel. A self expanding stent expands due to spring force following its implacement in the artery, after a restraining sheath is retracted from the compressed stent, or in the case of the Nitinol version, the stent assumes its expanded memory state after being warmed above the transition temperature of the Nitinol alloy (e.g., above 30° C.). Following the expansion process, when the balloon catheter is used, the balloon is removed from inside the stent and the catheter and other delivery apparatus is withdrawn. The lumen through the vessel is then substantially increased, improving blood flow.
After a stent or other endoluminal device is implanted, a clinical examination and either an angiography or an ultrasonic morphological procedure is performed to evaluate the success of the stent emplacement procedure in opening the diseased artery or vessel. These tests are typically repeated periodically, e.g., at six-month intervals, since restenosis of the artery may occur. Due to the nature of the tests, the results of the procedure can only be determined qualitatively, but not quantitatively, with any degree of accuracy or precision. It would clearly be preferable to monitor the flow of blood through the stent after its implacement in a vessel, both immediately following the treatment for the stenosis and thereafter, either periodically or on a continuous basis. Measurements of volumetric rate and/or flow velocity of the blood through the stent would enable a medical practitioner to much more accurately assess the condition of the stent and of the artery in which the stent is implanted. Currently, no prior art mechanism is available that is implantable inside a blood vessel for monitoring blood flow conditions through a stent.
Following stent implantation, it is difficult to monitor the condition of the affected area. Stents often fail after a period of time and for a variety of reasons. Several of the causal mechanisms are amenable to drug treatment. It is highly desirable in at least some of these cases to localize the drug treatment to the site of the graft or surgery. For example, when thrombus forms in a given area, thrombolytic drugs are capable of providing significant assistance in resolving the thrombosis, but may present problems such as hemorrhaging, if they also act in other portions of the patient's body.